Nearly 80% of Patients Show No Disease Progression After 10 Years on Roche’s CD20 Antibody Ocrevus

▎WuXi

Edited by Kant Content Team

Roche today announced the latest data on the anti-CD20 antibody Ocrevus (ocrelizumab). The data shows,After 10 years of continuous treatment with Ocrevus, 77% of patients with relapsing multiple sclerosis (RMS) still showed no disability progression, and 92% of RMS patients remained able to walk without assistance. In patients with primary progressive MS (PPMS), 36% showed no disability progression after 10 years, and 80% were still able to walk.The press release noted that Ocrevus is the first therapy that can benefit both RMS and PPMS patients by altering the course of multiple sclerosis, and it has already obtained 10-year follow-up data from its three Phase 3 clinical trials.

Multiple Sclerosis (MS) is a chronic disease that affects more than 2.8 million people worldwide. When the immune system erroneously attacks the myelin sheath that protects nerve cells in the central nervous system, it causes inflammation and nerve damage. This damage can lead to a wide range of symptoms, including muscle weakness, fatigue, and vision difficulties, which may eventually result in disability. The majority of MS patients experience their first symptoms between the ages of 20 and 40, makingThis disease has become the leading cause of non-traumatic disability among young people.An important goal in treating MS is to slow down, stop, and prevent disease activity and progression as early as possible.

Relapsing-remitting MS (RRMS) is the most common form of the disease, characterized by episodes of new or worsening symptoms followed by periods of recovery. Approximately 85% of MS patients are initially diagnosed with RRMS. PPMS is a debilitating condition characterized by steadily worsening symptoms, typically without distinct relapses or remissions. About 15% of MS patients are diagnosed with primary progressive disease.

Ocrevus is the first therapy approved for the treatment of RMS and PPMS.It is a humanized monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell considered to be a key factor in myelin and axonal damage.Based on preclinical studies, Ocrevus binds to the CD20 protein expressed on certain B cells, but not to stem cells or plasma cells, thus preserving important functions of the immune system.

The data released this time include not only the 10-year long-term efficacy data but also new safety data from 6,155 patients who received Ocrevus treatment across 12 clinical trials.Data Show Ocrevus Maintains Consistent Safety Over 10 YearsLong-term use of Ocrevus has not led to an increased risk of serious infections. In ongoing clinical trials, no new or unexpected safety signals have been observed in patients receiving Ocrevus treatment.

In addition,No increased risk of adverse pregnancy or infant outcomes was found in women with MS treated with Ocrevus based on Roche's accumulated pregnancy safety data in women with MS.Based on 1,145 reports of known pregnancy outcomes (including 512 cases of in-utero exposure to Ocrevus), the outcomes for these two groups were as follows: live birth rates of 83.6% and 84.2% (severe congenital anomaly rates of 1.3% and 1.6%, respectively); ectopic pregnancy rates of 1.2% and 0.8%; elective termination rates of 5.1% and 7.4%; spontaneous abortion rates of 10.0% and 7.4%; stillbirth rates.